Search results - Portal of Medical Data Models (MDM-Portal)

Itemgroups: Adverse Events,Concomitant Medication,Demographics,Disease Characteristics,Disposition,ECG,Laboratory,Laboratory Data,Medical History,Patient Reported Outcome,Substance Use,Surgery,Tumor Response,Vital Signs

Data Inventory for Clinical Trial Execution in the EHR4CR project. https://www.ncbi.nlm.nih.gov/pubmed/27875988 DOI for citation: 10.21961/MDM:17994

Lab tests cardiac surgery UKM - Lab tests

- 7/10/17 - 1 form, 2 itemgroups, 22 items, 2 languages

Itemgroups: Patient demographics,Lab tests

Lab tests form converted to ODM format. Routine documentation of University Hospital of Münster. Publication granted by Univ.-Prof. Dr. med. Sven Martens.

Efficacy and Safety of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus Lab panels NCT00516321

- 9/20/21 - 1 form, 6 itemgroups, 71 items, 1 language

Itemgroups: Chemistry,Haematology,Liver Chemistry Assessments,Renal Laboratory Parameters,Urinalysis Dipstick,Other Laboratory Screenings

The purpose of this study is to assess the ability of eltrombopag to maintain a platelet count sufficient to facilitate initiation of antiviral therapy, to minimise antiviral therapy dose reductions and to avoid permanent discontinuation of antiviral therapy. The clinical benefit of eltrombopag will be measured by the proportion of subjects who are able to achieve a Sustained Virological Response (SVR). NCT00516321 https://clinicaltrials.gov/ct2/show/NCT00516321 Study Type: Interventional Study Design: Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment Official Title: Randomised, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus (HCV) Infection Who Are Otherwise Eligible to Initiate Antiviral Therapy (Peginterferon Alfa-2a Plus Ribavirin

Safety and Efficacy of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus Infection Lab panels NCT00996216

- 9/20/21 - 1 form, 6 itemgroups, 49 items, 1 language

Itemgroups: Clinical Chemistry,Haematology,Liver Chemistry,Renal Assessments,Urinalysis Dipstick,Other Laboratory Screenings

The purpose of this study is to test the safety and tolerability of eltrombopag when used to increase and maintain platelet count. Platelet count to be maintained at a level sufficient to facilitate initiation of antiviral therapy, to minimize antiviral therapy dose reductions, and to avoid permanent discontinuation of antiviral therapy. NCT00996216 https://clinicaltrials.gov/ct2/show/NCT00996216 Study Type: Interventional Study Design: Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment Official Title: An Open-label, Multi-centre Rollover Study to Assess the Safety and Efficacy of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus (HCV) Infection Who Are Otherwise Eligible to Initiate Antiviral Therapy (Peginterferon Alfa-2a or Peginterferon Alfa-2b Plus Ribavirin)

Efficacy and Safety of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus Lab Panels NCT00529568

- 9/20/21 - 1 form, 6 itemgroups, 72 items, 1 language

Itemgroups: Chemistry,Haematology,Liver Chemistry Assessments,Renal Laboratory Parameters,Urinalysis Dipstick,Other Laboratory Screenings

The purpose of this study is to assess the ability of eltrombopag to maintain a platelet count sufficient to facilitate initiation of antiviral therapy, to minimise antiviral therapy dose reductions and to avoid permanent discontinuation of antiviral therapy. The clinical benefit of eltrombopag will be measured by the proportion of subjects who are able to achieve a Sustained Virological Response (SVR). NCT00529568 https://clinicaltrials.gov/ct2/show/NCT00529568 Study Type: Interventional Study Design: Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Treatment Official Title: Randomised, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus (HCV) Infection Who Are Otherwise Eligible to Initiate Antiviral Therapy (Peginterferon Alfa-2b Plus Ribavirin)

EHR4CR Complete Data Inventory - EHR4CR Data Inventory

- 2/10/17 - 1 form, 13 itemgroups, 122 items, 1 language

Itemgroups: Demographics,Diagnoses and Procedures,Vital Signs,Laboratory,Generic Laboratory Data,Medication,Adverse Events,Medical History,Clinical Findings,ECG,Patient Reported Outcome,Substance Use,Study Participation Status

Compilation of Feasibility, Patient Identification & Recruitment and Clinical Trial Execution data inventories. https://www.ncbi.nlm.nih.gov/pubmed/24410735 https://www.ncbi.nlm.nih.gov/pubmed/25991199 https://www.ncbi.nlm.nih.gov/pubmed/27875988

GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630 - Laboratory Examination - Treatment Period 2, Day 28, Pre-dose

- 4/29/22 - 1 form, 6 itemgroups, 47 items, 1 language

Itemgroups: Pregnancy Test,Drug Screen,Alcohol breath test,Carbon Monoxide test,Haematology,Clinical Chemistry

Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains Laboratory Examinations: Pregnancy test, Drug screen, alcohol breath test, carbon monoxide test, haematology and clinical chemistry. Time: Treatment Period 2, Day 28, Pre-dose.

Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients 105-040 - Study Continuitation Record, Vital Signs/Weight, Neurological Examination, Laboratory Comments, Clinical Laboratory Examination and Plasma Samples- Treatment Phase Study Week 22

- 4/20/22 - 1 form, 24 itemgroups, 70 items, 2 languages

Itemgroups: Administrative documentation,Study Subject Participation Status | Assessment Date ,Study Subject Participation Status | Clinical Trial Eligibility Criteria,Physical Examination Date,Vital signs | Body Weight,Neurologic Examination; Date in time |On examination - neurological findings ,Neurologic Examination | Abnormalities | Mental state,Neurologic Examination; Abnormalities | Speech and language finding,Neurologic Examination; Abnormalities | Cranial Nerves,Neurologic Examination; Abnormalities | Gait,Neurologic Examination | Abnormality | Physiologic Coordination,Neurologic Examination | Abnormality | Esthesia,Neurologic Examination | Abnormality | Muscle strength,Neurologic Examination | Abnormality | Muscle Tonus,Neurologic Examination | Abnormality | Reflex action,Laboratory; Specimen collection date ,Laboratory test finding ,Laboratory Results; Clinical Significance; Unexpected ,Laboratory examination; Clinical | Hematology (discipline) ,Laboratory examination; Clinical | Chemistry, Clinical ,Urinalysis; Urine dipstick test ,Serum pregnancy test (B-HCG) ,plasma concentration; Antiepileptic Agents,Plasma specimen

Study ID: 105-040 Clinical Study ID: 105-040 Study Title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Design Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Trade Name: lamictal Study Indication: Epilepsy, Partial

Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients 105-040 - Study Continuitation Record, Vital Signs/Weight, Neurological Examination, Laboratory Comments, Clinical Laboratory Examination and Urine Samples - Treatment Phase Study Week 12

- 4/20/22 - 1 form, 22 itemgroups, 64 items, 2 languages

Itemgroups: Administrative documentation,Study Subject Participation Status | Assessment Date ,Study Subject Participation Status | Clinical Trial Eligibility Criteria,Physical Examination Date,Vital signs | Body Weight,Neurologic Examination; Date in time |On examination - neurological findings ,Neurologic Examination | Abnormalities | Mental state,Neurologic Examination; Abnormalities | Speech and language finding,Neurologic Examination; Abnormalities | Cranial Nerves,Neurologic Examination; Abnormalities | Gait,Neurologic Examination | Abnormality | Physiologic Coordination,Neurologic Examination | Abnormality | Esthesia,Neurologic Examination | Abnormality | Muscle strength,Neurologic Examination | Abnormality | Muscle Tonus,Neurologic Examination | Abnormality | Reflex action,Laboratory; Specimen collection date ,Laboratory test finding ,Laboratory Results; Clinical Significance; Unexpected ,Laboratory examination; Clinical | Chemistry, Clinical ,Urinalysis; Urine dipstick test ,Serum pregnancy test (B-HCG) ,Urine Specimen Collection

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